Enliven’s Phase 1b ELVN‑001 leukemia pill shows competitive efficacy vs. Novartis and Terns CML TKIs
Enliven reported *initial Phase 1b ENABLE trial data for its oral BCR::*
ABL1 inhibitor ELVN‑001 in relapsed/refractory or TKI‑intolerant chronic myeloid leukemia (CML) based on a December 22, 2025 data cutoff.12
Among 60 heavily pretreated patients (53% had ≥4 prior TKIs; 67% prior asciminib; 32% prior ponatinib), ELVN‑001 achieved a cumulative major molecular response (MMR) rate of 69% by 24 weeks in the randomized 60 mg and 120 mg cohorts, with 53% in MMR at 24 weeks and 47% cumulative MMR in the 80 mg cohort.12
Deep molecular response (DMR) rates were *35% in the randomized 60/120 mg cohorts and 16% in the 80 mg cohort, comparing favorably to Phase 1 benchmark data for approved BCR::*
ABL1 TKIs such as Novartis’s asciminib.123
All patients who entered the study already in MMR maintained or deepened their response (100%), supporting durable disease control in a resistant/intolerant CML population.12
Safety profile was favorable across 60–120 mg once‑daily doses, with no maximum tolerated dose reached and no new safety signals; there was no clear dose‑response trend in efficacy or toxicity within this range.123
Media and investor commentary note that ELVN‑001’s early efficacy and safety profile in a heavily pretreated population *“compares favorably” to prior Phase 1 experiences with approved TKIs, including Novartis’s asciminib, positioning it as a potential best‑in‑class active‑site BCR::
ABL1 inhibitor*.13
According to coverage of Enliven’s update, the competitive context includes *Novartis’s asciminib (allosteric BCR::*
ABL1 inhibitor) and Terns Pharmaceuticals’ TERN‑701 (another BCR‑ABL1 inhibitor), with reports noting that Terns presented promising CML data at the ASH meeting, heightening competition in the space.2
ELVN‑001 is designed to retain activity against the T315I mutation, a key resistance mutation that limits many existing TKIs, which is strategically important for differentiation against both Novartis and Terns programs.12
On the back of these data, Enliven’s stock rose sharply (reports cite ~50%+ intraday gains) as investors viewed the results as clinically meaningful and commercially competitive in the CML market.246
Enliven plans additional Phase 1 data mid‑2026 and aims to initiate ENABLE‑2, a Phase 3 ELVN‑001 trial, in the second half of 2026, pending FDA alignment on dose and design—signaling confidence that the Phase 1b profile is strong enough to advance against established players like Novartis and emerging rivals like Terns.12
Sources:
1. https://www.prnewswire.com/news-releases/enliven-reports-positive-initial-phase-1b-data-for-elvn-001-in-cml-and-outlines-2026-clinical-milestones-302655863.html
2. https://www.investing.com/news/company-news/enliven-reports-positive-initial-phase-1b-data-for-elvn001-in-cml-93CH-4437359
3. https://finviz.com/news/271272/enliven-therapeutics-early-leukemia-drug-results-impress-stock-soars
4. https://www.benzinga.com/markets/biotech/26/01/49796641/enliven-therapeutics-early-leukemia-drug-results-impress-stock-soars
6. https://www.nasdaq.com/articles/enliven-stock-soars-promising-phase-1b-data-chronic-myeloid-leukaemia